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Prospective Evaluation of the Proceed Ventral Patch With and Without Laparoscopic Evaluation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01183325
First Posted: August 17, 2010
Last Update Posted: December 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Johnson & Johnson
Information provided by (Responsible Party):
University Hospital, Ghent
  Purpose

For small (2-3cm) ventral and umbilical hernias the discussion for primary suture repair or the use of mesh continues.

About 5 years ago the Ventralex patch was introduced, which combines a layer of PTFE mesh with a small polypropylene mesh and includes a circular memory ring. Despite the elegance of using this patch, recent experience showed several drawbacks both in design and efficacy (3).

With the recent development of the Proceed Ventral Patch (PVP), new elements have been introduced to overcome some of these issues.

The aim of this study is to evaluate the efficacy of clinical placement of the PVP in the intra-abdominal position in the treatment of small ventral hernias.


Condition Intervention
Umbilical Hernias Ventral Hernias Device: Proceed Ventral Patch placement

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicentric Evaluation of the Proceed Ventral Patch for Umbilical and Small Primary Ventral Hernias Less Than 3cm Diameter With One Year Follow-up

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Percentage of adequately placed patches [ Time Frame: At T 0 days ]

Secondary Outcome Measures:
  • Perioperative morbidity rate [ Time Frame: Within 30 days ]
  • Pre- and postoperative pain [ Time Frame: At T 0 day, T 30 days and T 1 year ]
  • Number of patients needed a repositioning of the patch [ Time Frame: At T 0 days ]
  • Reasons for inadequate positioning [ Time Frame: At T 0 days ]
  • Number of repositioning necessary [ Time Frame: At T 0 days ]
  • Complication ratio [ Time Frame: At 1 year ]
  • Recurrence rate at 1 year [ Time Frame: At 1 year ]

Enrollment: 160
Study Start Date: September 2009
Study Completion Date: September 2013
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Proceed Ventral Patch placement
Placement of a Proceed Ventral Patch for umbilical and small ventral hernias less than 3cm diameter with and without laparoscopic control
Device: Proceed Ventral Patch placement
Placement of a Proceed Ventral Patch for umbilical and small ventral hernias less than 3cm diameter with and without laparoscopic control

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patient
  • Written informed consent
  • Umbilical, primary ventral hernias smaller than 3cm diameter

Exclusion Criteria:

  • Hernias larger than 3cm
  • Recurrence
  • Children
  • Emergency cases
  • Incisional hernias
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01183325


Locations
Belgium
Imelda Hospital
Bonheiden, Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Johnson & Johnson
Investigators
Principal Investigator: Frederik Berrevoet, MD University Hospital, Ghent
  More Information

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01183325     History of Changes
Other Study ID Numbers: 2009/291
First Submitted: August 12, 2010
First Posted: August 17, 2010
Last Update Posted: December 5, 2014
Last Verified: December 2014

Keywords provided by University Hospital, Ghent:
Umbilical and small ventral hernias less than 3cm diameter

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Hernia, Umbilical
Pathological Conditions, Anatomical
Hernia, Abdominal
Infant, Newborn, Diseases